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Radiation

Radiotherapy + Androgen Deprivation Therapy for Prostate Cancer

Phase 2

Waitlist Available

Led By Benjamin Spieler, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biopsy confirmed adenocarcinoma of the prostate (including intraductal adenocarcinoma, excluding small cell carcinoma)

Suspicious peripheral zone or central gland lesion(s) on mpMRI.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2.5 year

Awards & highlights

Study Summary

This trial aims to compare two forms of radiotherapy to treat prostate cancer, and measure the effectiveness of each one.

Who is the study for?

Men aged 35-85 with confirmed adenocarcinoma of the prostate, stages T1-T3, Gleason score 6-10, and PSA ≤100 ng/mL. They must have no evidence of metastasis or prior pelvic radiotherapy/prostate surgery and be able to consent. Those with concurrent active cancers (except certain skin cancers/early-stage leukemia) or a history of cancer in remission for less than 5 years are excluded.Check my eligibility

What is being tested?

The UAdapt Trial is testing single high-dose radiotherapy (SDRT) on patients with favorable and unfavorable risk prostate cancer. It includes standard ADT care, FTLEAD, HypoLEAD treatments, and ultra-short-term Androgen Deprivation Therapy using Relugolix to see if they prevent disease failure one year post-radiotherapy.See study design

What are the potential side effects?

Possible side effects may include typical reactions from radiation therapy such as fatigue, skin changes in treated area, urinary issues like discomfort or frequency; bowel changes including diarrhea; erectile dysfunction; hormonal therapy side effects like hot flashes, mood swings; potential impact on fertility.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is confirmed as adenocarcinoma, not small cell carcinoma.

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My MRI shows a suspicious area in my prostate.

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My MRI shows a specific abnormal area in the central part of a gland.

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I have not had a complete prostate removal surgery.

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I will start hormone therapy before or during my radiation treatment.

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I am between 35 and 85 years old.

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My cancer has not spread to other parts of my body according to tests.

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I have not had radiation therapy to my pelvic area.

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My prostate cancer has a Gleason score between 6 and 10.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2.5 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2.5 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Incidence of Failure rate (FR)

Number of Treatment Related Acute toxicity

Number of Treatment Related Late toxicity

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Lattice extreme ablative dose followed by hypofractionated RT (HypoLEAD), uSTADT, Arm DExperimental Treatment4 Interventions

Participants in this group will receive LEAD RT with ultra short-term ADT followed by moderately hypofractionated RT (HypoLEAD) and standard of care ADT and will be followed for 5.5-8 years.

Group II: Lattice extreme ablative dose followed by hypofractionated RT (HypoLEAD), Arm CExperimental Treatment3 Interventions

Participants in this group will receive LEAD RT followed by moderately hypofractionated RT (HypoLEAD) and standard of care androgen deprivation therapy and will be followed for 5.5-8 years.

Group III: Focal Therapy lattice extreme ablative dose (FTLEAD), uSTADT, Arm BExperimental Treatment2 Interventions

Participants in this group will receive the FTLEAD treatment and ultra short-term androgen deprivation therapy (ADT) and will be followed for up to 5.5 years.

Group IV: Focal Therapy lattice extreme ablative dose (FTLEAD), RT Only, Arm AExperimental Treatment1 Intervention

Participants in this group will receive the FTLEAD treatment only and will be followed for up to 5.5 years.

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Varian Medical SystemsIndustry Sponsor

59 Previous Clinical Trials

3,699 Total Patients Enrolled

3 Trials studying Prostate Cancer

331 Patients Enrolled for Prostate Cancer

University of MiamiLead Sponsor

902 Previous Clinical Trials

409,936 Total Patients Enrolled

16 Trials studying Prostate Cancer

3,807 Patients Enrolled for Prostate Cancer

Benjamin Spieler, MDPrincipal InvestigatorUniversity of Miami

1 Previous Clinical Trials

24 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Focal Therapy lattice extreme ablative dose (FTLEAD), RT Only, Arm A been approved by the FDA?

"Since FTLEAD, RT Only, Arm A is currently in a Phase 2 clinical trial and there only exists data to support its safety but not efficacy, our team at Power has scored it with a score of 2 on the safety scale from 1-3."

Answered by AI

Does the trial accept participants over 35 years of age?

"This experimental research mandates that only individuals between the ages of 35 and 85 can participate. In contrast, there are 71 trials available for younger people aged 18 or less, with 1350 studies targeting seniors over 65 years old."

Answered by AI

Who is eligible to partake in this trial?

"All potential participants should be aged between 35 and 85 with a diagnosis of prostate cancer. This research project requires 80 individuals in total."

Answered by AI

Are there any unoccupied slots available in this experiment?

"According to the information provided on clinicaltrials.gov, this medical study is no longer recruiting individuals; its last update was dated October 26th 2023. Although it isn't currently accepting patients, there are 1353 other trials actively searching for participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The University of Miami Adapt (UAdapt) Trial

Benjamin Spieler 2024. "The University of Miami Adapt (UAdapt) Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06111313.